Study on the Use of Human Normal Immunoglobulin for Preventing Infections in Patients with Chronic Lymphocytic Leukemia and Secondary Immunodeficiency

3 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Chronic Lymphocytic Leukemia (CLL), which affects the blood and bone marrow. The study is investigating the use of a treatment called Panzyga, which is a solution containing human normal immunoglobulin. This treatment is being compared to a placebo to see if it can help prevent infections in patients with CLL who have a weakened immune system, a condition known as secondary immunodeficiency. The goal is to determine if Panzyga can effectively reduce the risk of infections in these patients.

During the study, participants will receive either Panzyga or a placebo through an intravenous infusion, which means the solution is given directly into a vein. The study is designed to be double-blind, meaning neither the patients nor the doctors will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of time, during which the safety and effectiveness of Panzyga in preventing infections will be closely monitored.

The main purpose of this study is to demonstrate the benefit of using Panzyga as a primary infection prevention method in patients with CLL who are undergoing treatment for their cancer. By comparing the occurrence of infections in patients receiving Panzyga versus those receiving a placebo, researchers hope to gather important information about the potential advantages of this treatment in managing the risk of infections in CLL patients with a compromised immune system.

1 joining the study

Upon joining the study, the patient is required to provide written and signed consent. This consent confirms understanding and agreement to participate in the study.

Eligibility is confirmed based on specific criteria, including a diagnosis of chronic lymphocytic leukemia (CLL) and low levels of immunoglobulin G (IgG).

2 treatment allocation

The study is double-blind, meaning neither the patient nor the doctor knows whether the patient receives the active treatment or a placebo.

Patients are randomly assigned to receive either the active treatment, Panzyga, or a placebo.

3 medication administration

The active treatment, Panzyga, is administered as an intravenous infusion. This means the medication is given directly into a vein through a needle.

The specific dosage and frequency of administration are determined by the study protocol and are monitored by the healthcare team.

4 monitoring and follow-up

Throughout the study, the patient is monitored for any signs of infection and other health changes.

Regular follow-up visits are scheduled to assess the patient’s health and the effectiveness of the treatment.

5 study completion

The study is expected to conclude by March 2025.

Upon completion, the patient’s health and any outcomes related to infection prevention are evaluated.

Who Can Join the Study?

  • Patients must have chronic lymphocytic leukemia (CLL), which is a type of cancer that affects a group of white blood cells called lymphocytes.
  • Patients can be either new to treatment or have had previous treatments that did not work or stopped working. They must be currently receiving treatment for CLL.
  • Patients must have hypogammaglobulinemia, which means they have low levels of a type of protein called immunoglobulin G (IgG) in their blood. This must be confirmed by a laboratory test showing IgG levels less than 5 grams per liter.
  • Patients must be 18 years of age or older.
  • Patients must provide written consent, meaning they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

  • Patients who have a known allergy or severe reaction to the study medication or its ingredients.
  • Patients with a history of severe allergic reactions to blood products.
  • Patients who are currently participating in another clinical trial.
  • Patients with a serious medical condition that might interfere with the study, such as uncontrolled heart disease or severe liver problems.
  • Patients who are pregnant or breastfeeding.
  • Patients with an active infection that requires treatment with antibiotics.
  • Patients who have received another investigational drug within the last 30 days.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures.
  • Patients who have had a recent vaccination with a live vaccine.
  • Patients with a condition that affects their immune system, other than the one being studied.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Evangelismos S.A. Athens Greece
University Of Debrecen Debrecen Hungary
University General Hospital Of Ioannina Ioannina Greece
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Aalborg University Hospital Aalborg Denmark
General University Hospital Of Patras Patras Greece
Region Midtjylland Aarhus Denmark
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Istituto Oncologico Veneto Padua Italy
Pratia Hematologia Sp. z o.o. Katowice Poland
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Wojewodzki Szpital Specjalistyczny W Legnicy Legnica Poland
Instytut Hematologii I Transfuzjologii Warsaw Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Azienda Sanitaria Locale Di Pescara Pescara Italy
Mfmdswsvs Iwbjmcdmfa Caoqvcgf Sagjpqai Ssx z ofps Warsaw Poland
Laybb Gktoqbq Hlgtwldv Oq Axmxex Athens Greece
Ajvyjzj Oofsjkqfrzg Uurccmbxxlcmh Crxkobriszaw Dpwtt Swdpdf E Dtnms Scrvazd Dw Tfvyjl Turin Italy
Ukbyvkatsdlsqc Chhnxoc Kithbqizy Gdansk Poland
Unfrabjqgi Dsflc Sccqz Dy Rvwg Lq Svmwibiq Rome Italy
Hekxheeh Uwstzpdarwfay Mdepwjh De Vikjddfvge Santander Spain
Fulonigpo Purx Lf Ibhsghqbcgnwa Bjoivnins Dex Hsomlbqi Ugskwcrgcpvkj Ld Pgg Madrid Spain
Wedzwpqnvas Whgxvfpwakwjesixkyjq Cnldzxj Osjfkdiwb I Tubloqvzawnvj Iz Mguyznmefjk W Loqqh Lodz Poland
Ssdoykii Pjdyunpwk Sfu z obmq Gdynia Poland
Grvomkgdafnksdqby Vbvxvzyhj Pbie Aukgib Ezbewguo Olgyzq Klzuwt Gyor Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
17.07.2020
Denmark Denmark
Not recruiting
17.07.2020
Greece Greece
Not recruiting
17.07.2020
Hungary Hungary
Not recruiting
17.07.2020
Italy Italy
Not recruiting
17.07.2020
Poland Poland
Not recruiting
17.07.2020
Spain Spain
Not recruiting
17.07.2020

Trial locations

Panzyga is a medication used in this clinical trial to help prevent infections in patients with chronic lymphocytic leukemia (CLL) who have a weakened immune system due to their cancer treatment. It is an immunoglobulin therapy, which means it contains antibodies that can help boost the immune system and protect against infections. The study aims to show how effective and safe Panzyga is in reducing the risk of infections in these patients.

Investigated Diseases:

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The progression of CLL varies among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:
2023-509737-39-00
Protocol code:
NGAM-12
NCT ID:
NCT04502030
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Evaluating the efficacy of pirtobrutinib and epcoritamab in patients with untreated Richter transformation of chronic lymphocytic leukemia

    Recruiting

    3 1 1 1
    Austria Denmark Germany Ireland
  • A study of emavusertib and zanubrutinib in patients with chronic lymphocytic leukemia and other B-cell cancers.

    Recruiting

    2 1 1 1
    Investigated Drugs:
    Italy Spain